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CSV Specialist - Data Integrity & QA

LocationBeerse, Belgium
Business SectorBiotechnology
Contact email
Job ref26902
Publishedabout 1 hour ago

Job Description

As a member of the Quality Assurance CSV group within a global life sciences supply chain organization, you will be responsible for ensuring the quality and compliance of diverse systems across a major Belgian campus. This role covers both commercial and clinical activities, supporting a robust quality culture across multiple local sites.

In this position, you will act as a local expert and Process Owner for Data Integrity. Your focus will be on assessing local systems and equipment, defining risks, and leading remediation activities. You will play a pivotal role in a Community of Practice, guiding Subject Matter Experts (SMEs) through data flow mapping and risk assessments to ensure continuous regulatory readiness.

Essential Requirements

  • Master’s degree in a scientific field or equivalent professional experience.

  • Minimum of 3 years of experience within the pharmaceutical industry.

  • Core technical expertise in cGMP and CSV compliance (including 21 CFR Part 11 and EudraLex Volume 4/Annex 11).

  • Required hands-on skills in Data Integrity remediation activities and Computerized System Validation.

  • Required scientific/technical knowledge of GAMP5 and international Data Integrity guidelines.

Preferred Requirements

  • Experience leading multi-functional teams to define risks and vulnerabilities for site-specific equipment.

  • Advanced skills in Data Flow Mapping and performing platform-based risk assessments.

  • Experience representing Data Integrity matters during regulatory audits and inspections.

  • Previous exposure to Small Molecules platforms or large-scale manufacturing campuses.

  • Strong ownership mindset with the ability to communicate fluently in both English and Dutch.

Practicalities

  • Start Date: March 30, 2026

  • Contract Duration: 9 months

  • Location: Beerse, Belgium (Hybrid: 40-60% from home)

  • Additional: This role involves collaboration with Engineering and IT teams to ensure compliance during the introduction of new systems and processes.

Interested?

Interviews and offers can move quickly. Send your CV to Oluali Titelman at o.titelman@panda-int.com or call +31 (0)20 2044 502 today to secure your spot in the process.

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